The effect of etoricoxib on the pharmacokinetics of oral contraceptives in healthy participants

J Clin Pharmacol. 2009 Jul;49(7):807-15. doi: 10.1177/0091270009337131. Epub 2009 May 14.

Abstract

The pharmacokinetics of oral contraceptive (OC) components, ethinyl estradiol (EE) and norethindrone (NET), were evaluated after coadministration with etoricoxib in 3 double-blind, randomized, 2-period crossover studies of healthy women. There were 16, 39, and 24 participants enrolled in studies 1 (part I, part II), and 2, respectively. Each participant received triphasic OC (EE 35 microg/NET 0.5 mgx7 days, 0.75 mgx7 days, 1.0 mgx7 days) throughout each 28-day period. OC was coadministered with 21 days of etoricoxib daily followed by placebo for 7 days; the alternate period followed the reverse regimen (placebo to etoricoxib). Study 1 (part I) examined concurrent (morning) administration of OC/etoricoxib 120 mg, study 1 (part II) examined staggered (morning/night) administration of OC/etoricoxib 120 mg, and study 2 examined concurrent (morning) administration of OC/etoricoxib 60 mg. Coadministration of OC and etoricoxib 120 mg once daily was associated with a approximately 50% to 60% increase in EE concentrations, whereas etoricoxib 60 mg once daily was associated with a approximately 37% increase in EE concentrations. Coadministration of OC and etoricoxib was generally well tolerated. A clinically important change in NET AUC0-24 h was not observed. Adverse events included dyspepsia, diarrhea, headache, nausea, fatigue, loss of appetite, and taste disturbance.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Contraceptives, Oral, Combined / administration & dosage*
  • Contraceptives, Oral, Combined / adverse effects
  • Contraceptives, Oral, Combined / pharmacokinetics*
  • Cyclooxygenase Inhibitors / administration & dosage*
  • Cyclooxygenase Inhibitors / adverse effects
  • Cyclooxygenase Inhibitors / pharmacology
  • Drug Combinations
  • Drug Interactions
  • Etoricoxib
  • Female
  • Headache / chemically induced
  • Humans
  • Mestranol / administration & dosage*
  • Mestranol / adverse effects
  • Mestranol / pharmacokinetics*
  • Middle Aged
  • Nausea / chemically induced
  • Norethindrone / administration & dosage*
  • Norethindrone / adverse effects
  • Norethindrone / pharmacokinetics*
  • Pyridines / administration & dosage*
  • Pyridines / adverse effects
  • Pyridines / pharmacology*
  • Serum Albumin / metabolism
  • Sex Hormone-Binding Globulin / metabolism
  • Sulfones / administration & dosage*
  • Sulfones / adverse effects
  • Sulfones / pharmacology*

Substances

  • Contraceptives, Oral, Combined
  • Cyclooxygenase Inhibitors
  • Drug Combinations
  • Pyridines
  • Serum Albumin
  • Sex Hormone-Binding Globulin
  • Sulfones
  • Norinyl
  • Mestranol
  • Norethindrone
  • Etoricoxib